Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood

Parkinson's Disease Clinical Trial

Official title:

Pilot Study: Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104401
• Other study ID #: 00000
• Status: Completed
• Phase: Phase 1
• First received: April 2, 2014
• Last updated: August 19, 2014
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This research will help us to understand whether transcranial direct current stimulation (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in people with Parkinson's disease and related disorders. Some of the disorders that will be studied to understand if tDCS can be useful include Parkinson's Disease, Multi-System Atrophy (MSA) and progressive supranuclear palsy (PSP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parkinson's disease or a related disorder (e.g. Multiple Systems Atrophy) as diagnosed by a neurologist specializing in Movement Disorders

• Age >= 18 years

Exclusion Criteria:

• Skull defect at or near site of tDCS delivery.

• History of a significant stroke or traumatic brain injury.

• History of other brain conditions that could impact interpretation of results (such as MS, brain tumor, encephalitis).

• Presence of implanted electrical or metallic devices in the head or body (examples include cardiac pacemakers or defibrillators, Baclofen pumps, deep brain stimulators, ventricular shunts with metallic parts, vagus nerve stimulators)

• Presence of ferrous metal in the head (except titanium; for instance shrapnel)

• History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common antidepressants)

• Pregnancy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• tDCS
tDCS will be applied with a Soterix CT tDCS Device with a HD-tDCS 4x1 Multi-Channel Stimulation Interface. During stimulation, a low level of constant DC electrical current (1-2 mA) will be applied via the electrodes. Current will be ramped up over 10-60 seconds, and typically causes very mild tingling and itching sensations. The current will be applied for no more than 20 minutes per session, at which time the current is ramped down over 10-60 seconds. Subjects will be seated in a chair throughout tDCS administration. Subjects will receive tDCS 5 days/week for 4 weeks.

Locations

Country	Name	City	State
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Ferrell Family Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Motor and Speech Symptoms of Parkinson's Disease or Related Disorders	We will perform an assessment of motor function using Part III of the Unified Parkinson's Disease Rating Scale (UPDRS), timed test of gait, and patient self-assessment. Speech functions will be assessed with sentence repetition,evaluation of spontaneous speech, and other standard language tests. The assessment will also include other measures and questionnaires (e.g. Bech Depression Inventory) to be filled out by the patient and his/her family.	16 weeks	No
Secondary	Improvement of Neuropsychiatric Symptoms of Parkinson's Disease or Related Disorders		16 weeks	No